NCT00813657

Brief Summary

The investigators investigated the effects of a supervised maternal exercise training program (performed during the 2nd and 3rd trimesters of pregnancy) on maternal-newborn unit health outcomes in a group of previously sedentary healthy women. A matched control group was assessed over the same time period. Given the fact that most studies in the field have used aerobic exercises, here the investigators largely focused on very light resistance, toning exercises.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2000

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2008

Completed
Last Updated

December 23, 2008

Status Verified

December 1, 2008

Enrollment Period

2.2 years

First QC Date

December 22, 2008

Last Update Submit

December 22, 2008

Conditions

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL
Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Women in the intervention group were enrolled in three sessions/week of individually supervised, resistance exercise training performed over the second and third trimester of pregnancy (in total 26 weeks, \~80 training sessions). Heart rate (HR) was carefully and individually controlled (≤80% of age-predicted maximum HR value, 220-age) through a heart rate monitor during the training sessions. In brief, each session consisted of 35-40 minutes of exercise divided in a light intensity (≤60% maximal heart rate) warm-up period (\~8 minutes), followed by toning and very light resistance exercises (\~20 minutes) and a light intensity cool-down (\~8 minutes) period. Resistance exercises were performed with barbells (≤3kg per exercise) or low-to-medium resistance bands (Therabands).

Lifestyle counseling

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • sedentary (not exercising \>20 minutes on \>3 days per week)
  • with singleton
  • not at high risk for preterm delivery (no more than one previous preterm deliveries)
  • women planning to give birth in the same obstetrics hospital department (Hospital Severo Ochoa, Madrid, Spain)

You may not qualify if:

  • not being under medical follow-up throughout the entire pregnancy period were not included in the study
  • women having serious medical condition that prevent them from exercising safely

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Birth WeightAnemiaDiabetes, Gestational

Interventions

Exercise

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2008

First Posted

December 23, 2008

Study Start

January 1, 2000

Primary Completion

March 1, 2002

Study Completion

March 1, 2002

Last Updated

December 23, 2008

Record last verified: 2008-12